VO2 Max: In Vivo Model for Functional Red Cell Testing. Can RECESS be Explained?
Completed · Phase 4
Conditions studied: Healthy
In brief
This is a single-center, randomized, partially blinded study to determine whether 42-day old red blood cells (RBCs) deliver oxygen as effectively as 7-day old RBCs and also to determine whether transfusion with 28-day old RBCs is non-inferior to 7-day old RBCs with respect to oxygen delivery. In this study, subjects will be randomized to be transfused with 2 units of autologous (one's own) RBCs that are either 7-, 28-, or 42-days old. Endpoints include changes in exercise duration and VO2 max (test of oxygen consumption/delivery) between groups.
Key facts
- Study ID
- NCT02918851
- Run by
- Stony Brook University
- People needed
- 42
- Starts
- 2017-01-01
- Expected to finish
- 2019-11-20
- Last updated by the study team
- 2021-04-08
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Habitual exerciser defined as ≥ 30 minutes of at least moderate or high intensity exercise ≥ 3 times per week. After consent, and at the subsequent screening visit, a VO2 max test will be performed, and subjects with a low value (< 35 mL/kg/min) will be excluded (screen failure). Based on our previous experience, we anticipate that <10% of the subjects will fall into this category
- Calculated total blood volume (TBV) ≥4,500 mL using an established formula:
- Men: (0.006012 x H3) + (14.6 x W) + 604 = TBV
- Women: (0.005835 x H3) + (15 x W) + 183 = TBV [H=height in inches; W=weight in pounds]
- Has access to transportation to visit the blood collection facility and to return to Stony Brook for all study visits.
You may not qualify if…
- Any significant acute or chronic medical illness or problem, including, but not limited to, diabetes, hypertension, cardiac disease, asthma, chronic obstructive lung disease
- Current or recent (last 60 days) tobacco or nicotine use
- History of sickle cell trait or disease or any other acquired or hereditary hematological abnormality
- History of fainting or other significant adverse reaction during phlebotomy or donation of blood
- Known prolonged corrected QT interval (or evidence of such at screening) on electrocardiogram defined as >470 ms
- Known or suspected illicit drug or alcohol abuse
- Known or suspected HIV, Hepatitis B, or Hepatitis C infection
- History of thrombophilia or anticoagulant therapy
- Pregnancy
- Obesity defined as BMI>30
- Recent history of blood donation: a) Single whole blood unit donation within the past 8 weeks; b) Double RBC donation by apheresis within the past 16 weeks; or c) Plasma donation by apheresis within the past 4 weeks
- Inadequate RBC mass based on TBV <4500 ml (above) or screening Hb <14 g/dL
Where it is running
- Stony Brook Medicine — Stony Brook, New York, United States
Full record on ClinicalTrials.gov
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